# The Kids FACE FEARS Pragmatic Randomized Trial of Therapist-Led vs Guided Internet Cognitive Behavioral Therapy for Pediatric Anxiety: Rationale and Methods

## TL;DR

This study compares two forms of cognitive behavioral therapy for treating anxiety in children and teens to improve access and effectiveness in real-world pediatric settings.

## Contribution

The first large-scale, multisite trial comparing therapist-led and guided internet-based CBT for pediatric anxiety in diverse, real-world settings.

## Key findings

- The trial compared therapist-led and guided internet-based CBT for youth anxiety in urban pediatric care.
- It aimed to assess how different levels of therapist involvement and technology affect treatment outcomes and accessibility.
- The study included English- and Spanish-speaking families, enhancing diversity and representativeness.

## Abstract

Pediatric anxiety constitutes a serious public health concern. Cognitive behavioral therapy (CBT) is a gold standard treatment, preferred by families over pharmacological options, but barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist involvement and differential technologies to overcome barriers, but little is known about their effectiveness in typical care settings, as well as in pediatric care. The Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps.

The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing therapist-led CBT (telehealth, office-based, or hybrid) with guided internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating anxiety in youth (7-18 years old) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric health care sites affiliated with major medical centers in 4 metropolitan regions. This article describes the study’s rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation.

Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision making and help tailor treatment selections for underserved youth with anxiety.

Kids FACE FEARS Comparative Effectiveness Research; https://clinicaltrials.gov/study/NCT03707158

Cognitive behavioral therapy (CBT) is a “gold standard” treatment for youth anxiety, but barriers limit CBT accessibility. This study protocol describes novel ways of improving access in the Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial—a multisite randomized trial comparing two CBT formats (ie, therapist-led CBT and guided internet-based CBT) with different levels of technology and therapist involvement. This study focused on English- and Spanish- speaking youth with anxiety in urban pediatric sites affiliated with major medical centers. Findings may better inform treatment recommendations in pediatric settings.